MAUDE Adverse Event Report: FRESENIUS HEMOCARE GMBH C.A.T.S PLUS CONTINUOUS AUTOTRANSFUSION SYSTEM

Model Number N/A

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

Event Description

Problem reported: fresenius continuous auto transfusion system (cats) with bmi 21132 made a popping sound during the middle of an exploratory laparotomy in operating room 22, and a small plume of smoke was seen emanating from the rear portion of the machine.There was also the distinctive odor of an electrical fire, but no flames were seen.The equipment was immediately unplugged and removed from operating room 22.Facilities was also immediately notified of the equipment issue and that this particular cats was placed at the 5n operating rom front desk with an orange repair tag.No injuries occurred to the patient or employees as a result of this equipment malfunction.

Event Description

Problem reported: fresenius continuous auto transfusion system (cats) with bmi (b)(6) made a popping sound during the middle of an exploratory laparotomy in or 22, and a small plume of smoke was seen emanating from the rear portion of the machine.There was also the distinctive odor of an electrical fire, but no flames were seen.The equipment was immediately unplugged and removed from or 22.Facilities was also immediately notified of the equipment issue and that this particular cats was placed at the 5n or front desk with an orange repair tag.No injuries occurred to the patient or employees as a result of this equipment malfunction.Fse found power entry module burnt.Upon inspection found that possible fluid infiltration caused unit to suffer reported damage.Replaced power entry module, push button and push button cap.By the description of the local fse, the intrusion of a medium into the device caused a pcba to malfunction.Therefore the device was rendered inoperable.No clear root cause could be identified.The mode of intrusion of a medium and the cause for it could not clearly be identified.

• Brand Name: C.A.T.S PLUS CONTINUOUS AUTOTRANSFUSION SYSTEM
• Type of Device: C.A.T.S PLUS
• Manufacturer (Section D): FRESENIUS HEMOCARE GMBH; gruener weg 10; friedberg hessen, D-611 69; GM D-61169
• Manufacturer (Section G): FRESENIUS HEMOCARE GMBH; gruener weg 10; friedberg hessen, D-611 69; GM D-61169
• Manufacturer Contact: vicki mckee ; 3 corporate drive; lake zurich, IL 60047 ; 8475500157
• MDR Report Key: 7281100
• MDR Text Key: 100560596
• Report Number: 3004634229-2018-00001
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 9005081
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2018
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1